Tethered system for cryogenic treatment

ABSTRACT

A tethered system for cryogenic treatment is disclosed in which a hand piece having an elongate probe with a distal tip and a flexible length, at least one infusion lumen positioned through or along the elongate probe, and a liner may be tethered to a base station having a reservoir of a cryoablative fluid via a connection having an elongate flexible body. The connection defines at least one fluid lumen for delivery of the cryoablative fluid from the reservoir and to the infusion lumen within the hand piece.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/605,630 filed May 25, 2017, the content of which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to medical devices. In particular, thepresent invention relates to methods and apparatus for the cryoablativetreatment of tissue regions using a hand piece and base tethered to oneanother.

BACKGROUND OF THE INVENTION

While the delivery of energy via radiofrequency ablation is used inseveral arenas, radiofrequency ablation has several major downsides,including incomplete ablation, frequent lack of visualization duringcatheter insertion, potential for overlap during treatment (with someareas receiving twice as much energy as other areas), charring oftissues and requirements for frequent debridement, frequent requirementsfor additional doses of energy after debridement, and potentialperforation of the body cavity or lumen due to the rigidity of the RFelectrodes.

Other treatments involve the delivery of a cryogenic agent for ablatingthe contacted tissue within the body of a subject. Yet such systemsrequire a connection to a reservoir of a cryoablative fluid for deliveryof the fluid as well as withdrawal of any exhausted fluid from thepatient body.

The current state of the art would benefit from minimally invasivedevices and methods which deliver thermal energy to a desired area orextract energy from a desired area using a system which is ergonomic andfacilitates ease of use by the practitioner.

SUMMARY OF THE INVENTION

A cryoablation treatment assembly may include a base station having areservoir housing and electronics which may be detached entirely from ahand piece having a sheath and liner assembly such that the treatmentassembly is formed as a two-part or multi-component system which may betethered or otherwise connected to one another. The hand piece may beseparated from the base station which incorporates the reservoir andcontroller. A flexible connection may attach the hand piece with thebase station where the hand piece may either be permanently coupled tothe base station via the connection or where the hand piece may bedetachable from the connection and/or from the base station.

One variation of a treatment system may generally comprise a hand piecehaving an elongate probe with a distal tip and a flexible length, atleast one infusion lumen positioned through or along the elongate probe,and a liner expandably enclosing the probe such that a cryoablativefluid introduced through one or more unobstructed openings along theinfusion lumen is sprayed into contact with an interior surface of theliner and coats the interior surface. The system may also include a basestation having a reservoir of the cryoablative fluid and a connectionhaving an elongate flexible body coupling the hand piece and the basestation, wherein the connection defines at least one fluid lumen fordelivery of the cryoablative fluid from the reservoir and to theinfusion lumen within the hand piece.

One variation of a method for treating tissue may generally comprisesecuring a reservoir assembly within a receiving channel of a basestation, and positioning a hand piece in proximity to a tissue region ofinterest, wherein the hand piece has an elongate probe with a distal tipand a flexible length, at least one infusion lumen positioned through oralong the elongate probe, and a liner expandably enclosing the probesuch that a cryoablative fluid introduced through one or moreunobstructed openings along the infusion lumen is sprayed into contactwith an interior surface of the liner and coats the interior surface.The method may also include infusing the cryoablative fluid from thereservoir assembly through a connection having an elongate flexible bodyand in fluid communication with the infusion lumen within the handpiece.

In controlling or modulating the flow of the cryoablative agent, theinflow reservoir or canister valve which is fluidly coupled with thereservoir or canister may be utilized. Such a valve may generallycomprising a valve body, a reservoir interface extending from the valvebody and configured for fluidly coupling with the reservoir or canistercontaining the cryoablative agent, a modulation control interfacedefined along the body and configured for fluidly coupling to amodulation control interface, a valve stem seated within a valve stemchannel defined within the valve body, an inflow lumen defined throughthe valve body and extending between the reservoir interface and themodulation control interface, where the valve stem is movable between afirst position which obstructs the inflow lumen and a second positionwhich opens the inflow lumen, a venting lumen defined through the valvebody and extending between the reservoir interface and a vent opening,and a vent piston which is movable between a first position whichobstructs the venting lumen and a second position which opens theventing lumen. Alternatively, the valve stem may be configured toinclude three positions including a first position which obstructs theinflow lumen, a second position which opens the inflow lumen, and athird optional position which opens the venting lumen.

To facilitate the liner expanding and conforming readily against thetissue walls of the uterus, the liner may be inflated with a gas orliquid. Once the elongate shaft has been introduced through the cervixand into the uterus, the distal opening of the shaft may be positioneddistal to the internal os and the liner may be deployed either fromwithin the shaft or from an external sheath. The liner may be deployedand allowed to unfurl or unwrap within the uterus. The cooling probe maybe introduced through the shaft and into the liner interior. As thecryoablative agent (e.g., cryoablative fluid) is introduced into anddistributed throughout the liner interior, the exhaust catheter may alsodefine one or more openings to allow for the cryoablative fluid to ventor exhaust from the interior of the liner.

A coolant reservoir, e.g., nitrous oxide canister, may be fluidlycoupled to the handle and/or elongate shaft via a coolant valve whichmay be optionally controlled by the microcontroller. The coolantreservoir may be in fluid communication with the cooling probe assemblyand with the interior of the balloon. Additionally, an exhaust lumen incommunication with the elongate probe and having a back pressure valvemay also include a pressure sensor where one or both of the backpressure sensor and/or valve may also be in communication with themicrocontroller.

Yet another variation of the treatment assembly may incorporate ahousing having a handle and a reservoir housing extending from andattached directly to the handle. The sheath having the liner may extendfrom the housing while an actuator may be located, for instance, alongthe handle to enable the operator to initiate the cryoablativetreatment. A reservoir or canister fully containing the cryoablativefluid may be inserted and retained within the reservoir housing. Thereservoir housing and/or the handle may further incorporate a reservoirengagement control which may be actuated, e.g., by rotating the controlrelative to the handle, to initially open fluid communication with thereservoir or canister to charge the system for treatment.

In an alternative variation, the reservoir housing and the electronicsmay be detached entirely from the sheath and liner assembly such thatthe treatment assembly is formed as a two-part or multi-component systemwhich may be tethered or otherwise connected to one another. Rather thanincorporating the reservoir housing and controller, the hand piece maybe separated from a base station which incorporates the reservoir andcontroller. A flexible connection may attach the hand piece with thebase station where the hand piece may either be permanently coupled tothe base station via the connection or where the hand piece may bedetachable from the connection and/or from the base station.

Because the treatment system is separated into at least two componentswhich are in communication with one another, the system may provide anergonomic hand piece which is relatively light yet still providesefficient treatment to the patient while remaining attached to its basestation via the flexible connection. With the base station separated andhousing the reservoir and multiple electronic and actuation components,the hand piece may be easily handled by the practitioner duringtreatment relative to the base station and the patient body.

The hand piece may optionally incorporate a display, e.g., LCD display,which shows various treatment parameters or indicators of the assembly.A control, e.g., thumbwheel, slide, etc., may also be incorporated forcontrolling functions such as positioning of the sheath and/or probe orother function. One or more actuators, e.g., button, switch, etc., maybe incorporated as well for controlling functions such as infusing thecryoablative fluid into the liner or exhausting the fluid from theliner.

Other mechanisms such as a potentiometer, e.g., linear potentiometer,may be incorporated for detecting and/or monitoring the position of thesheath relative to the hand piece housing. A pressure sensor may also beincorporated for detecting and/or monitoring the pressure within theliner prior to, during, and/or after a treatment. Additionally, aninflow control, e.g., inflow solenoid, may be incorporated into the handpiece for controlling the inflow of the cryoablative fluid into the handpiece from the base station.

While the hand piece may be detachable from the base station and/orconnection, an infusion attachment including, e.g., sheath, liner, andcooling probe, may also be removable and/or replaceable from the rest ofthe hand piece allowing for the replacement of the infusion attachmentwhile reusing the hand piece. The hand piece may be maintained at atreatment location for sterilization while the infusion attachment maybe disposed, refurbished, or repurposed on-site or at another location.

The connection may be coupled to the hand piece via a releasableconnector, e.g., quick-connect mechanism, and it may be coupled to thebase station also via a second releasable connector, e.g., quick-connectmechanism. The connection may enable the connection between the handpiece and base station to allow for the passage of various fluids andsignals such as the cryoablation fluid, high pressure gas, electricalsignals, pneumatic signals, etc. while remaining flexible enough so thatthe hand piece may be moved and adjusted relative to the patientindependently of the base station which may remain in a stationaryposition relative to the patient.

The base station has a housing which may include a display, e.g., LCDtouchscreen, etc., for enabling interaction with or the display ofparameters, messages, or warnings to the practitioner. A programmablemicrocontroller may be integrated within the base station and is inelectrical communication with the hand piece either through theconnection or wirelessly to control the treatment parameters as well asto receive and process signals from the hand piece such as pressurereadings, sheath positioning, etc. or any number of other signals. Themicrocontroller may also control the various parameters within the basestation as well.

The base station may also incorporate a pump which may be fluidlycoupled to the hand piece and used to draw the spent exhaust from theinterior of the liner, through the hand piece and connection, and thenthrough the base station to, e.g., an exhaust collection assembly. Apneumatics controller, which may also include a pump, may beincorporated into the base station and may be in fluid communicationwith the liner for controlling the infusion or withdrawal of air withinthe liner, e.g., when monitoring the liner for leaks or for initiallyexpanding the liner within the patient body. At least one actuator,e.g., button, may also be integrated for initiating treatment steps orfacilitating control of the base station during treatment. A reservoirassembly may also be included within the base station but may beremovable from the base station.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of an integrated treatment assembly.

FIG. 1B shows an example of the assembly advanced through the cervix andinto the uterus where the sheath may be retracted via the handleassembly to deploy the balloon.

FIG. 1C shows a perspective view of a cryoablation assembly having ahandle assembly which may integrate the electronics and pump assemblywithin the handle itself.

FIG. 1D shows the handle assembly in a perspective exploded viewillustrating some of the components which may be integrated within thehandle.

FIG. 1E shows an example of the system operation during a pre-treatmentpuff up process.

FIG. 1F shows an example of the system operation during a treatmentprocess.

FIG. 1G shows an example of the system operation during a thawing andventing process.

FIGS. 2A and 2B show cross-sectional side views of yet another variationof a cooling probe which utilizes a single infusion line in combinationwith a translatable delivery line.

FIGS. 3A and 3B show top and perspective views of the expanded linerwith four pairs of the open delivery ports exposed in apposed direction.

FIGS. 4A to 4C show side and assembly views of another variation of thetreatment assembly.

FIG. 5A shows one variation of a tethered system having a hand pieceseparated from a base station.

FIG. 5B shows a representative assembly view of the tethered treatmentassembly having various components.

FIG. 6 shows a schematic view of one variation of the hand piece wherean infusion attachment may be removably coupled to a distal end of thehousing of the hand piece via a coupling mechanism.

FIGS. 7A and 7B show end and side views, respectively, of the connectorfor the hand piece.

FIG. 8 shows a schematic view of one variation illustrating how thereservoir assembly may provide the cryoablative fluid once secured tothe base station.

FIG. 9 illustrates a schematic view of an example of how the basestation may incorporate a releasable connector for attachment of thebase station to an external exhaust reservoir.

FIG. 10 shows a schematic view of the flexible connection incorporatingan actuator cable capable of transmitting a linear movement through theconnector and to the hand piece.

FIG. 11A shows a schematic view of some of the components which may beincorporated within a housing of the base station.

FIG. 11B shows a schematic side view of another variation of thereservoir using a sipper tube.

FIG. 12 shows a schematic view of the reservoir assembly removed fromthe base station.

DETAILED DESCRIPTION OF THE INVENTION

The cooling probe 22 as well as the balloon assembly may be variouslyconfigured, for instance, in an integrated treatment assembly 10 asshown in the side view of FIG. 1A. In this variation, the assembly 10may integrate the elongate shaft 18 having the liner or balloon 20extending therefrom with the cooling probe 22 positioned translatablywithin the shaft 18 and liner 20. A separate translatable sheath 12 maybe positioned over the elongate shaft 18 and both the elongate shaft 18and sheath 12 may be attached to a handle assembly 14. The handleassembly 14 may further comprise an actuator 16 for controlling atranslation of the sheath 12 for liner 20 delivery and deployment.

With the sheath 12 positioned over the elongate shaft 18 and liner 20,the assembly 10 may be advanced through the cervix and into the uterusUT where the sheath 12 may be retracted via the handle assembly 14 todeploy the liner 20, as shown in FIG. 1B. As described above, once theliner 20 is initially deployed from the sheath 12, it may be expanded byan initial burst of a gas, e.g., air, carbon dioxide, etc., or by thecryoablative fluid. In particular, the tapered portions of the liner 20may be expanded to ensure contact with the uterine cornu. The handleassembly 14 may also be used to actuate and control a longitudinalposition of the cooling probe 22 relative to the elongate shaft 18 andliner 20 as indicated by the arrows.

In another variation of the treatment assembly, FIG. 1C shows aperspective view of a cryoablation assembly having a handle assembly 24which may integrate the electronics and pump assembly 28 within thehandle itself. An exhaust tube 26 may also be seen attached to thehandle assembly 24 for evacuating exhausted or excess cryoablative fluidor gas from the liner 20. Any of the cryoablative fluids or gasesdescribed herein may be utilized, e.g., compressed liquid-to-gas phasechange of a compressed gas such as nitrous oxide (N₂O), carbon dioxide(CO₂), Argon, etc. The cooling probe 22 may be seen extending fromsheath 12 while surrounded or enclosed by the liner or balloon 20.Hence, the handle assembly 24 with coupled cooling probe 22 and liner 20may provide for a single device which may provide for pre-treatmentpuff-up or inflation of the liner 20, active cryoablation treatment,and/or post-treatment thaw cycles.

The handle assembly 24 may also optionally incorporate a display forproviding any number of indicators and/or alerts to the user. Forinstance, an LCD display may be provided on the handle assembly 24 (orto a separate control unit connected to the handle assembly 24) wherethe display counts down the treatment time in seconds as the ablation isoccurring. The display may also be used to provide measured pressure ortemperature readings as well as any number of other indicators, symbols,or text, etc., for alerts, instructions, or other indications. Moreover,the display may be configured to have multiple color-coded outputs,e.g., green, yellow, and red. When the assembly is working through theideal use case, the LED may be displayed as a solid green color. Whenthe device requires user input (e.g. when paused and needing the user topress the button to re-start treatment) the LED may flash or displayyellow. Additionally, when the device has faulted and treatment isstopped, the LED may flash or display a solid red color.

FIG. 1D shows the handle assembly 24 in a perspective exploded view toillustrate some of the components which may be integrated within thehandle 24. As shown, the liner 20 and sheath 12 may be coupled to asheath bearing assembly 32 and slider base block assembly 34 forcontrolling the amount of exposed treatment length along the coolingprobe 22 (and as described in further detail below). An actuatablesheath control 36 may be attached to the slider base block assembly 34for manually controlling the treatment length of the cooling probe 22 aswell. Along with the electronics and pump assembly 28 (which mayoptionally incorporate a programmable processor or controller inelectrical communication with any of the mechanisms within the handle24), an exhaust valve 30 (e.g., actuated via a solenoid) may be coupledto the exhaust line 26 for controlling not only the outflow of theexhausted cryoablation fluid or gas but also for creating or increasinga backpressure during treatment, as described in further detail below.

In one example of how the handle assembly 24 may provide for treatment,FIGS. 1E to 1G illustrate schematic side views of how the components maybe integrated and utilized with one another. As described herein, oncethe sheath 12 and/or liner 20 has been advanced and initially introducedinto the uterus, the liner 20 may be expanded or inflated in apre-treatment puff up to expand the liner 20 into contact against theuterine tissue surfaces in preparation for a cryoablation treatment. Asillustrated in the side view of FIG. 1E, a pump 38 integrated within thehandle assembly 24 may be actuated and a valve 42 (e.g., actuatable orpassive) fluidly coupled to the pump 38 may be opened (as indicatedschematically by an “O” over both the pump 38 and valve 42) such thatambient air may be drawn in through, e.g., an air filter 40 integratedalong the handle 24, and passed through an air line 44 within the handleand to an exhaust block 46. The exhaust block 46 and air line 44 may befluidly coupled to the tubular exhaust channel which extends from thehandle 24 which is further attached to the cooling probe 22. As the airis introduced into the interior of the liner 20 (indicated by thearrows), the liner 20 may be expanded into contact against thesurrounding uterine tissue surface.

A cryoablative fluid line 48 also extending into and integrated withinthe handle assembly 24 may be fluidly coupled to an actuatable valve 50,e.g., actuated via a solenoid, which may be manually closed orautomatically closed (as indicated schematically by an “X” over thevalve 50) by a controller to prevent the introduction of thecryoablative fluid or gas into the liner 20 during the pre-treatmentliner expansion. An infusion line 52 may be fluidly coupled to the valve50 and may also be coupled along the length of the sheath 12 and probe22, as described in further detail below. The exhaust valve 30 coupledto the exhaust line 26 may also be closed (as indicated schematically byan “X” over the valve 30) manually or automatically by the controller toprevent the escape of the air from the exhaust block 46.

During this initial liner expansion, the liner 20 may be expanded in agradual and controlled manner to minimize any pain which may beexperienced by the patient in opening the uterine cavity. Hence, theliner 20 may be expanded gradually by metering in small amounts of air.Optionally, the pump 38 may be programmed and controlled by a processoror microcontroller to expand the liner 20 according to an algorithm(e.g., e.g. ramp-up pressure quickly to 10 mm Hg and then slow-down theramp-up as the pressure increases to 85 mm Hg) which may be stopped orpaused by the user. Moreover, the liner 20 may be expanded to a volumewhich is just sufficient to take up space within the uterine cavity.After the initial increase in pressure, the pressure within the liner 20may be optionally increased in bursts or pulses. Moreover, visualization(e.g., via a hysteroscope or abdominal ultrasound) may be optionallyused during the controlled gradual expansion to determine when theuterine cavity is fully open and requires no further pressurization. Inyet another variation, the liner 20 may be cyclically inflated anddeflated to fully expand the liner. The inflations and deflations may bepartial or full depending upon the desired expansion.

In yet another alternative variation, the system could also use anamount of air pumped into the liner 20 as a mechanism for detectingwhether the device is in a false passage of the body rather than theuterine cavity to be treated. The system could use the amount of timethat the pump 38 is on to track how much air has been pushed into theliner 20. If the pump 38 fails to reach certain pressure levels within apredetermined period of time, then the controller may indicate that thedevice is positioned within a false passage. There could also be a limitto the amount of air allowed to be pushed into the liner 20 as a way todetect whether the probe 22 has been pushed, e.g., out into theperitoneal cavity. If too much air is pushed into the liner 20 (e.g.,the volume of air tracked by the controller exceeds a predeterminedlevel) before reaching certain pressures, then the controller mayindicate the presence of a leak or that the liner 20 is not fullyconstrained by the uterine cavity. The liner 20 may also incorporate arelease feature which is configured to rupture if the liner 20 is notconstrained such that if the system attempts to pump up the liner 20 totreatment pressure (e.g., 140 mmHg), the release feature will rupturebefore reaching that pressure.

Once the liner 20 has been expanded sufficiently into contact againstthe uterine tissue surface, the cryoablation treatment may be initiated.As shown in the side view of FIG. 1F, the air pump 38 may be turned offand the valve 42 may be closed (as indicated schematically by an “X”over the pump 38 and valve 42) to prevent any further infusion of airinto the liner 20. With the cryoablative fluid or gas pressurized withinthe line 48, valve 50 may be opened (as indicated schematically by an“O” over the valve 50) to allow for the flow of the cryoablative fluidor gas to flow through the infusion line 52 coupled to the valve 50.Infusion line 52 may be routed through or along the sheath 12 and alongthe probe 22 where it may introduce the cryoablative fluid or gas withinthe interior of liner 20 for infusion against the liner 20 contactedagainst the surrounding tissue surface.

During treatment or afterwards, the exhaust valve 30 may also be opened(as indicated schematically by an “O” over the valve 30) to allow forthe discharged fluid or gas to exit or be drawn from the liner interiorand proximally through the cooling probe 22, such as through the distaltip opening. The fluid or gas may exit from the liner 20 due to apressure differential between the liner interior and the exhaust exitand/or the fluid or gas may be actively drawn out from the linerinterior, as described in further detail herein. The spent fluid or gasmay then be withdrawn proximally through the probe 22 and through thelumen surrounded by the sheath 12, exhaust block 46, and the exhausttube 26 where the spent fluid or gas may be vented. With the treatmentfluid or gas thus introduced through infusion line 52 within the liner20 and then withdrawn, the cryoablative treatment may be applieduninterrupted.

Once a treatment has been completed, the tissue of the uterine cavitymay be permitted to thaw. During this process, the cryoablative fluiddelivery is halted through the infusion line 52 by closing the valve 50(as indicated schematically by an “X” over the valve 50) whilecontinuing to exhaust for any remaining cryoablative fluid or gasremaining within the liner 20 through probe 22, through the lumensurrounded by sheath 12, and exhaust line 26, as shown in FIG. 1G.Optionally, the pump 38 and valve 42 may be cycled on and off and theexhaust valve 30 may also be cycled on and off to push ambient air intothe liner 20 to facilitate the thawing of the liner 20 to the uterinecavity. Optionally, warmed or room temperature air or fluid (e.g.,saline) may also be pumped into the liner 20 to further facilitatethawing of the tissue region.

As the spent cryoablative fluid or gas is removed from the liner 20, adrip prevention system may be optionally incorporated into the handle.For instance, a passive system incorporating a vented trap may beintegrated into the handle which allows exhaust gas to escape butcaptures any vented liquid. The exhaust line 26 may be elongated toallow for any vented liquid to evaporate or the exhaust line 26 may beconvoluted to increase the surface area of the exhaust gas tube topromote evaporation.

Alternatively, an active system may be integrated into the handle orcoupled to the handle 24 where a heat sink may be connected to atemperature sensor and electrical circuit which is controlled by aprocessor or microcontroller. The heat sink may promote heat transferand causes any liquid exhaust to evaporate. When the temperature of theheat sink reaches the boiling temperature of, e.g., nitrous oxide(around −86° C.), the handle may be configured to slow or stop thedelivery of the cryoablative fluid or gas to the uterine cavity.

The pre-treatment infusion of air as well as the methods for treatmentand thawing may be utilized with any of the liner, probe, or apparatusvariations described herein. Moreover, the pre-treatment, treatment, orpost-treatment procedures may be utilized altogether in a singleprocedure or different aspects of such procedures may be used in varyingcombinations depending upon the desired results.

Additionally and/or optionally, the handle 24 may incorporate anorientation sensor to facilitate maintaining the handle 24 in adesirable orientation for treatment. One variation may incorporate aball having a specific weight covering the exhaust line 26 such thatwhen the handle 24 is held in the desirable upright orientation, thetreatment may proceed uninterrupted. However, if the handle 24 moved outof its desired orientation, the ball may be configured to roll out ofposition and trigger a visual and/or auditory alarm to alert the user.In another variation, an electronic gyroscopic sensor may be used tomaintain the handle 24 in the desired orientation for treatment.

FIGS. 2A and 2B show cross-sectional side views of yet another variationof a cooling probe which utilizes a single infusion line in combinationwith a translatable delivery line. To accommodate various sizes andshapes of uterine cavities, the cooling probe may have a slidingadjustment that may be set, e.g., according to the measured length ofthe patient's uterine cavity. The adjustment may move along the sheathalong the exhaust tube as well as the delivery line within the infusionline. The sheath may constrain the liner 20 and also control itsdeployment within the cavity.

In this variation, an infusion line 52 (as described above) may passfrom the handle assembly and along or within the sheath and into theinterior of liner 20. The infusion line 52 may be aligned along theprobe 22 such that the infusion line 52 is parallel with a longitudinalaxis of the probe 22 and extends towards the distal tip 66 of the probe22. Moreover, the infusion line 52 may be positioned along the probe 22such that the line 52 remains exposed to the corners of the liner 20which extend towards the cornua. With the infusion line 52 positionedaccordingly, the length of the line 52 within the liner 20 may havemultiple openings formed along its length which act as delivery portsfor the infused cryoablative fluid or gas. A separate translatingdelivery line 64, e.g., formed of a Nitinol tube defining an infusionlumen therethrough, may be slidably positioned through the length of theinfusion line 52 such that the delivery line 64 may be moved (asindicated by the arrows in FIG. 2A) relative to the infusion line 52which remains stationary relative to the probe 22.

The openings along the length of the infusion line 52 may be positionedsuch that the openings are exposed to the sides of the interior of theliner 20, e.g., cross-drilled. As the cryoablative fluid or gas isintroduced through the delivery line 64, the infused cryoablative fluidor gas 68 may pass through the infusion line 52 and then out through theopenings defined along the infusion line 52. By adjusting thetranslational position of the delivery line 64, the delivery line 64 mayalso cover a selected number of the openings resulting in a number ofopen delivery ports 60 as well as closed delivery ports 62 which areobstructed by the delivery line 64 position relative to the infusionline 52, as shown in the top view of FIG. 2B.

By translating the delivery line 64 accordingly, the number of opendelivery ports 60 and closed delivery ports 62 may be adjusted dependingon the desired treatment length and further ensures that only desiredregions of the uterine tissue are exposed to the infused cryoablativefluid or gas 68. Once the number of open delivery ports 60 has beensuitably selected, the infused cryoablative fluid or gas 68 may bypassthe closed delivery ports 62 obstructed by the delivery line 64 and thefluid or gas may then be forced out through the open delivery ports 60in a transverse direction as indicated by the infusion spray direction69.

The terminal end of the infusion line 52 may be obstructed to preventthe distal release of the infused fluid or gas 68 from its distal end.Although in other variations, the terminal end of the infusion line 52may be left unobstructed and opened.

FIGS. 3A and 3B show top and perspective views of the expanded liner 20with four pairs of the open delivery ports 60 exposed in apposeddirection. Because the infused fluid or gas 68 may be injected into theliner 20, e.g., as a liquid, under relatively high pressure, theinjected cryoablative liquid may be sprayed through the open deliveryports 60 in a transverse or perpendicular direction relative to thecooling probe 22. The laterally infused cryoablative fluid 70 may sprayagainst the interior of the liner 20 (which is contacted against thesurrounding tissue surface) such that the cryoablative liquid 70 coatsthe interior walls of the liner 20 due to turbulent flow causing heavymixing. As the cryoablative liquid 70 coats the liner surface, thesprayed liquid 70 may absorb heat from the tissue walls causing rapidcooling of the tissue while also evaporating the liquid cryogen to a gasform that flows out through the cooling probe 22. This rapid cooling andevaporation of the cryoablative liquid 70 facilitates the creation of afast and deep ablation over the tissue. During treatment, thetemperature within the cavity typically drops, e.g., −86° C., within 2-3seconds after the procedure has started. While the interior walls of theliner 20 are first coated with the cryoablative liquid 70, a portion ofthe cryoablative liquid 70 may no longer change phase as the procedureprogresses.

While four pairs of the open delivery ports 60 are shown, the number ofexposed openings may be adjusted to fewer than four pairs or more thanfour pairs depending on the positioning of the delivery line 64 and alsothe number of openings defined along the infusion line 52 as well as thespacing between the openings. Moreover, the positioning of the openingsmay also be adjusted such that the sprayed liquid 70 may spray inalternative directions rather than laterally as shown. Additionallyand/or alternatively, additional openings may be defined along otherregions of the infusion line 52.

Further variations of the treatment assembly features and methods whichmay be utilized in combination with any of the features and methodsdescribed herein may be found in the following U.S. Pat. Nos. 9,283,022;9,486,267; 9,498,274; 9,445,860; 9,492,217; 9,510,887; 9,517,100;9,492,218; 9,408,657; 8,858,543; 9,277,952; and 9,603,650. They may alsobe found in the following U.S. patent application Ser. No. 14/029,641filed Sep. 17, 2013 (U.S. Pub. 2015/0080869); Ser. No. 14/019,928 filedSep. 6, 2013 (U.S. Pub. 2014/005648); Ser. No. 14/265,799 (U.S. Pub.2015/0289920); and Ser. No. 15/065,684 (U.S. Pub. 2016/0183999).

Each of the patent applications above is incorporated herein byreference in its entirety and for any purpose herein.

Yet another variation of the treatment assembly 80 is shown in the sideand partial cross-sectional side views of FIGS. 4A and 4B whichillustrate a housing 82 having a handle 84 and a reservoir housing 88extending from and attached directly to the handle 84. FIG. 4C furtherillustrates a perspective assembly view of the treatment assembly 80 andsome of its components contained internally.

The sheath 12 having the liner 20 may extend from the housing 82 whilean actuator 86 may be located, for instance, along the handle 84 toenable the operator to initiate the cryoablative treatment. A reservoiror canister 92 fully containing the cryoablative agent (as describedherein) may be inserted and retained within the reservoir housing 88.The reservoir housing 88 and/or the handle 84 may further incorporate areservoir engagement control 90 which may be actuated, e.g., by rotatingthe control 90 relative to the handle 84, to initially open fluidcommunication with the reservoir or canister 92 to charge the system fortreatment.

The reservoir or canister 92 may be inserted into the reservoir housing88 and into secure engagement with a reservoir or canister valve 94which may be coupled to the reservoir engagement control 90. The valve94 may be adjusted to open the reservoir or canister 92 for treatment orfor venting of the discharged cryoablative agent during or aftertreatment. An inflow modulation control unit 96 (e.g., an actuatablesolenoid mechanism) may be coupled directly to the reservoir or canistervalve 94 and the cryoablative fluid line 48 may be coupled directly tothe modulation control unit 96 and through the sheath 12 and into fluidcommunication within the liner 20, as described herein.

During or after treatment, the discharged cryoablative fluid may beevacuated through the exhaust block 46 contained within the housing andthen through the exhaust line 98 coupled to the exhaust block 46. Theexhaust line 98 may extend through the handle 84 and the reservoirhousing 88 and terminate at an exhaust line opening 100 which may beattached to another exhaust collection line, as further describedherein.

In yet another variation, the reservoir housing 88 and the electronicsmay be detached entirely from the sheath 12 and liner 20 assembly suchthat the treatment assembly is formed as a two-part or multi-componentsystem which may be tethered or otherwise connected to one another. Oneexample is illustrated in the perspective assembly view of FIG. 5A whichshows a tethered system 110 having a hand piece 112 which mayincorporate the sheath 12 and cooling probe 22 having the delivery line64 surrounded by the liner 20, as described above. However, rather thanincorporating the reservoir housing 88 and controller, the hand piece112 may be separated from a base station 114 which incorporates thereservoir and controller, as described in further detail below. Aflexible connection 116 may attach the hand piece 112 with the basestation 114 where the hand piece 112 may either be permanently coupledto the base station 114 via the connection 116 or where the hand piece112 may be detachable from the connection 116 and/or from the basestation 114.

FIG. 5B illustrates a representative assembly view of the tetheredtreatment assembly having various components and further shows in onevariation how the hand piece 112 and base station 114 may be separatelyconfigured. The hand piece 112 may optionally incorporate a display 118,e.g., LCD display, which shows various treatment parameters orindicators of the assembly. A control 120, e.g., thumbwheel, slide,etc., may also be incorporated for controlling functions such aspositioning of the sheath 12 and/or probe 22 or other function. One ormore actuators 122, e.g., button, switch, etc., may be incorporated aswell for controlling functions such as infusing the cryoablative fluidinto the liner 20 or exhausting the fluid from the liner 20.

Other mechanisms such as a potentiometer 124, e.g., linearpotentiometer, may be incorporated for detecting and/or monitoring theposition of the sheath 12 relative to the hand piece 112 housing. Apressure sensor 126 may also be incorporated for detecting and/ormonitoring the pressure within the liner 20 prior to, during, and/orafter a treatment. Additionally, an inflow control 128, e.g., inflowsolenoid, may be incorporated into the hand piece 112 for controllingthe inflow of the cryoablative fluid into the hand piece 112 from thebase station 114.

While the hand piece 112 may be detachable from the base station 114and/or connection 116, an infusion attachment 168 including, e.g.,sheath 12, liner 20, and cooling probe 22, may also be removable and/orreplaceable from the rest of the hand piece 112 allowing for thereplacement of the infusion attachment 168 while reusing the hand piece112. The hand piece 112 may be maintained at a treatment location forsterilization while the infusion attachment 168 may be disposed,refurbished, or repurposed on-site or at another location.

The connection 116 may be coupled to the hand piece 112 via a releasableconnector 130, e.g., quick-connect mechanism, and it may be coupled tothe base station 114 also via a second releasable connector 132, e.g.,quick-connect mechanism. Connection 116 may enable the connectionbetween the hand piece 112 and base station 114 to allow for the passageof various fluids and signals such as the cryoablation fluid, highpressure gas, electrical signals, pneumatic signals, etc. whileremaining flexible enough so that the hand piece 112 may be moved andadjusted relative to the patient independently of the base station 114which may remain in a stationary position relative to the patient.

The base station 114 has a housing which may include a display 134,e.g., LCD touchscreen, etc., for enabling interaction with or thedisplay of parameters, messages, or warnings to the practitioner. Adisposable sterile cover, e.g., transparent cover, may be optionallyprovided for placement upon or over the display 134 or the entire basestation 114 so that the practitioner may interact with the display 134during a procedure while maintaining sterility of the base station 114.Additionally and/or alternatively in other variations, a foot pedal 135may be coupled to the base station 114 to provide a user interface tothe practitioner for interacting with the base station 114.

A programmable microcontroller 136 may be integrated within the basestation 114 and is in electrical communication with the hand piece 112either through the connection 116 or wirelessly to control the treatmentparameters as well as to receive and process signals from the hand piece112 such as pressure readings, sheath positioning, etc. or any number ofother signals. The microcontroller 136 may also control the variousparameters within the base station 114 as well.

The base station 114 may also incorporate a pump 140 which may befluidly coupled to the hand piece 112 and used to draw the spent exhaustfrom the interior of the liner 20, through the hand piece 112 andconnection 116, and then through the base station 114 to, e.g., anexhaust collection assembly. A pneumatics controller 138, which may alsoinclude a pump, may be incorporated into the base station 114 and may bein fluid communication with the liner 20 for controlling the infusion orwithdrawal of air within the liner 20, e.g., when monitoring the liner20 for leaks or for initially expanding the liner 20 within the patientbody. At least one actuator 142, e.g., button, may also be integratedfor initiating treatment steps or facilitating control of the basestation 114 during treatment. A reservoir assembly 144 may also beincluded within the base station 114 but may be removable from the basestation 114, as described in further detail below.

Turning now to the hand piece 112, FIG. 6 shows a schematic view of onevariation of the hand piece 112 where the infusion attachment 168, asmentioned above, may be removably coupled to a distal end of the housingof the hand piece via a coupling mechanism 178 which may secure theinfusion attachment 168 for use but which may also de-couple theinfusion attachment 168 for replacement or disposal. The infusionattachment 168 may include a base 176 which couples to the housing ofthe hand piece 112 and which also supports components such as theinsulating sheath 12 from which the liner 20 and cooling probe 22extend. The infusion attachment 168 may also include the incorporate aninflow line 150 through which the cryoablative fluid 152 is infused intothe liner interior and an exhaust line 156 through which the exhaust 158is drawn from the liner interior. The base 176 may also optionallyincorporate one or more lights 174, e.g., LED, for providingillumination as the device is inserted into the patient body.

Additionally and/or optionally, the sheath 12 may also incorporate oneor more heating elements 175, e.g., strip heaters, along the length or aportion of the length of the sheath 12. The heating elements 175 may bepositioned along an outer surface of the sheath 12 or within the sheath12. During use, these heating elements 175 may be heated when thecryoablative fluid is delivered through the sheath 12 during a procedureand/or when the exhaust is evacuated from the liner 20 interior in orderto prevent damage to tissue, e.g., cervix, contacting the sheath 12.

Because the heating elements 175 may draw its power from the basestation 114 power supply 190 (or from a stationary outlet) whichprovides for a larger power source, the heating elements 175 may enablethermal protection for the contacted cervical tissue while potentiallyeliminating insulation for the sheath 12. This may result in a sheath 12having a relatively smaller diameter which in turn may result in greatersheath 12 flexibility for increased comfort for the patient duringdevice insertion, use, and removal.

Within the hand piece 112, its distal end may be configured to fluidlycouple with the inflow line 150 and exhaust line 156 within the infusionattachment 168 when the two are coupled to one another. A valve 154,e.g., solenoid valve, may be in fluid communication with the inflow line150 to provide control for metering the flow of cryoablative fluid intothe liner 20 and a pressure sensor 162 may be in fluid communicationwith exhaust line 156 via pressure line 164 to enable monitoring of thepressure within the interior of the liner 20. An electrical line 166 maybe connected to the pressure sensor 162 for transmitting electricalsignals to and/or from the pressure sensor 162 to the microcontroller136 located within the base station 114. Although the pressure sensor162 may be housed within the hand piece 112 itself to ensure the fastesttransmission of pressure readings within the liner 20, the pressuresensor may instead be housed externally of the hand piece 112 such aswithin the base station 114 or external to the system in which case thepressure sensor may communicate with the microcontroller wirelessly orvia a wired connection.

Additionally, one or more control mechanisms such as control 170, e.g.,thumbwheel, slide, etc., may be incorporated for controlling featuressuch as deploying or retracting the sheath 12. Also, one or moreactuators such as actuator 172, e.g., button, switch, etc., may beintegrated for actuating any number of features or for providing variousinputs into the device. A display 160, e.g., LCD display, for promptingand alerting the user through the treatment as well as for displayingany number of parameters to the user may also be integrated into thehand piece 112. The hand piece 112 may also incorporate one or morevisual, auditory, or haptic mechanisms (e.g., LED, speaker, vibratorymotor, etc.) to provide an alert to the user for any number of actionsor alarms.

Although various electronics are illustrated within both the basestation 114 and hand piece 112, other variations of the system mayutilize the various electronics and/or components positioned entirelywithin the base station 114 or entirely within the hand piece 112. Thecomponents disposed within the base station 114 are not intended to belimiting and other variations of the system may incorporate any numberof components within the hand piece 112 and base station 114.

The various connections for the hand piece 112 may be routed throughconnector 130, which is further illustrated respectively in the end andside views of FIGS. 7A and 7B. As described herein, the connector 130may be removably detached via a securement mechanism which not onlymechanically attaches the hand piece 112 to the connector 116, but alsoseals and maintains the high pressure lines and low pressure pneumaticlines as well as maintains the electrical signals to and from themicrocontroller. The end view shown in FIG. 7A illustrates one variationof how the individual lumens may be positioned relative to one another.As shown, the ablation agent lumen 180, exhaust lumen 182, and pneumaticlumen 184 may be disposed relative to one another and one or moreelectrical contacts and actuator lumens 186 may be aligned adjacent toone another.

Additionally and/or optionally, the connector 130 may have embeddedelectronics which are configured to identify the connection to eitherthe appropriate hand piece 112 and/or base station 114 and verify thatthe connection was properly made using, e.g., proximity sensors, halleffects sensors, RFID chips, etc. The base station 114 and hand piece112 may also incorporate embedded electronics to verify authenticity ofthe connected device or verify that the user is not attempting to re-usethe device. For instance, both the hand piece 112, base station 114, andthe base station reservoir 192 may utilize embedded or connectedelectronics such as RFID markers for tracking or identificationpurposes.

As described above, the reservoir assembly 144 is secured within thebase station 114 and may be removed at the completion of treatment forrefurbishing or disposal. The reservoir assembly 144 may contain notonly the reservoir of the cryoablative fluid for the treatmentprocedure, but the assembly 144 may also incorporate a power supply orbattery for providing power to the base station 114 and hand piece 112as well. Moreover, the assembly 144 may also optionally incorporate anynumber of additional components as well.

The entire system, including the base station 114, may be used in asterile condition or maintained within a sterile field during aprocedure while the reservoir 192 and/or electronics may be removed forrefurbishment and reuse after the completion of a procedure. Because thesystem is provided as several components, the reservoir 192 and/orelectronics may be alternatively provided in a non-sterile condition foruse in the base station 114 which may be maintained in a sterilecondition. In yet another alternative, the base station 114, includingthe reservoir 192 and/or electronics, may be maintained outside of thesterile field while the hand piece 112 and connector 116 are maintainedwithin the sterile field during a procedure.

FIG. 8 shows a schematic view of one variation illustrating how thereservoir assembly 144 may provide the cryoablative fluid once securedto the base station 114. The assembly 144 may incorporate the powersupply 190, as shown, while the reservoir 192 contains the cryoablativefluid within. Once secured to the base station 114, a port 194 may bealigned within a receiving channel within the base station 114 to engagewith a base fluid lumen 196 leading from the port 194 to the baseconnector 132 to and the hand piece 112. A base exhaust lumen 198 mayalso extend within the base station 114 from the base connector 132while urged via pump 140 through an exhaust lumen 200 for deposition orinfusion within an exhaust reservoir 202 which may be separated from thebase station 114 and connected via the exhaust lumen 200. Alternatively,the exhaust from exhaust lumen 198 may be vented to the environmentinstead. In the event that a separate exhaust reservoir 202 is used,such an exhaust reservoir may take the form of an expandable liner, bag,or other container. Examples of exhaust reservoirs which may be usedwith the devices disclosed herein are described in further detail inU.S. patent application Ser. No. 15/288,766 filed Oct. 7, 2016, which isincorporated herein by reference in its entirety and for any purpose.

In other variations, the exhaust reservoir 202 may be integrated withinthe base station 114 or fluidly coupled externally of the base station114. The exhaust reservoir 202 may be comprised of a pressurizedcontainer, such as a bottle, which receives the exhaust and is thenpressurized by the pump 140 within the exhaust reservoir 202. Thepressurized container may be disengaged from the pump 140 for disposingthe pressurized exhaust contained within and then reattached later.

By having the exhaust reservoir 202 and pump 140 separated from the handpiece 112, the back pressure in the hand piece 112 may be isolated fromthe external environment. For instance, a user may connect thescavenging suction from pump 140 to the exhaust port on the base station114 and any pressure or vacuum drawn on the base station 114 from thevacuum may be isolated so as to not impact the hand piece 112 and distalend pressure.

FIG. 9 illustrates a schematic view of an example of how the basestation 114 may incorporate a releasable connector 204, e.g.,quick-connect mechanism, for attachment of the base station 114 to anexternal exhaust reservoir 202. Also shown are the display 134, actuator142, and reservoir assembly 144, as described above.

Aside from the transfer of fluids between the base station 114 and handpiece 112, the flexible connection 116 may also incorporate an actuatorcable 214, e.g., cable, wire, or any structural element which is capableof transmitting a linear movement through the connector 116 and to thehand piece 112, as shown in the schematic view of FIG. 10. The actuatorcable 214 may transmit a linear movement to the same actuator cable 214or a separate cable within the hand piece 112 which may be coupled tothe sheath 210. The actuator cable 214 can be coupled to the hand piece112 via connector 130 and/or to the base station 114 via connector 132.Once coupled to the base station 114 and hand piece 112, the actuatorcable 214 may be translated, e.g., in the direction of actuation 218,via a motor 216 such that the linear movement of the actuator cable 214is transmitted through the connector 116, hand piece 112, and to thesheath 210 so that the sheath 210 and/or delivery line 64 may be moveddistally or proximally as indicated by the longitudinal translation 212during use in a procedure to not only translate the sheath 210 but toalso cover a selected number of the openings resulting in a number ofopen delivery ports 60, as described herein.

Turning back to the base station 114, FIG. 11A shows a schematic view ofsome of the components which may be incorporated within a housing. Thereservoir assembly 144, which may be removable from the housing of thebase station 114, may incorporate the power supply 190, such as abattery, within an enclosure to which the reservoir 192 is connected andcontains the cryoablative fluid 220 within. The reservoir 192 may have aport 194 extending or defined along the reservoir 192 as shown in thisvariation as extending from a bottom surface of the reservoir 192 whenthe reservoir assembly 144 is secured within the base station 114.Because the port 194 extends from a bottom surface of the reservoir 192,the cryoablative fluid 220 contained within may effectively flow out ofthe reservoir 192 thereby eliminating any need for a sipper tube orother lumen to extend into the interior of reservoir 192 and alsoensures that the entire contents of the reservoir 192 may be emptied.

In the event that the reservoir 192 is oriented so that its port 194extends from a top surface when secured within the base station 114, thereservoir 192 may be vented of excess fluid 220 by using a sipper tube256 which extends into the interior of the reservoir 192, as shown inFIG. 11B. This variation of the reservoir 192 utilizing the sipper tube256 may be used in combination with any of the features of the basestation 114 or the system as described herein.

In the event that the reservoir 192 is used as a heat sink, the ventinglumen 259 may be separate from the sipper tube 256. A valve 258, whichis fluidly coupled to a venting lumen 259, may remain closed during usewhile fluid lumen 196 is opened. When fluid lumen 196 is closed, valve258 may be opened in order to vent any gaseous cryoablative fluid 220″.If the cryoablative fluid 220, is drawn up through the sipper tube 256in liquid form 220′, it will not extract the heat from the internalreservoir walls. (If the cryoablative fluid 220 were to convert into itsgaseous form, heat from the internal reservoir walls would beextracted.) The gaseous form 220″ of the cryoablative fluid 220 exitingfrom the separate venting lumen 259 through the port in the top of thereservoir 192 reduces the pressure within the reservoir 192 which willcause the liquid cryoablative fluid 220′ at the bottom of the reservoir192 to convert to a gaseous form 220″ before exiting through the ventinglumen 259 in the top of the reservoir 192. This liquid-to-gas phasechange within the reservoir 192 will extract heat from the walls of thereservoir 192 causing the reservoir 192 temperature to drop and therebyusing the reservoir 192 as a heat sink.

The cryoablative fluid 220 may be retained within the reservoir 192 by aseal 244 within the port 194 such that when the reservoir assembly 144is secured within a reservoir assembly receiving channel 222 definedwithin the base station 114, a piercing manifold 246 extending withinthe receiving channel 222 is positioned to pierce the seal 244 andextend at least partially within the reservoir 192 in a sealed manner toenable the fluid within to flow into the manifold 246 and through thebase fluid lumen 196 which extends through the base station 114 to theconnection 132. In other variations, rather than utilizing a piercingmanifold 246, the port receiving channel may instead be configured toopen a valve into the reservoir 192 and the manifold 246 may be omitted.This variation may be utilized particularly if the reservoir 192 is tobe reused.

A pressure sensor 250 may be optionally fluidly connected to base fluidlumen 196 so that the internal pressure from the fluid 220 within thereservoir 192 may be monitored by the microcontroller 232 which may beconnected to the pressure sensor 250 via electrical connection 254. Thepressure sensor 250 may also be configured as a mass sensor so that thepressure sensor 250 can be used to verify that the reservoir 192 isready for treatment.

The microcontroller 232 may be electrically connected to not only to thecomponents within the base station 114 but it may also communicate withthe hand piece 112 and the various components within the hand piece 112via one or more electrical connections 234 which may connect from themicrocontroller 232 to the hand piece 112 via the connections 234through the connection 116.

In other variations, rather than having a reservoir 192 be replaceable,the base station 114 may alternatively house a reservoir which ispermanently integrated within the base station 114 such that thereservoir 192 is refillable by an external source. The base station 114may have internal regulators and pressure switches to automate theprocess of filling the internal reservoir.

The base exhaust lumen 198 may also be seen extending from the connector132 and through the base station 114 in fluid communication with thepump 140, which may also be in electrical communication with andcontrolled by the microcontroller 232, and through an exhaust lumen 200.A thermal mass/evaporator 248 connected to the pump 140 may bepositioned within the receiving channel 222 of the base station 114 suchthat the thermal mass/evaporator 248 contacts the reservoir 192 directlyin order to facilitate evaporation of any remaining liquid cryogen thatis exhausted.

Additionally, the base station 114 may also include a pneumatic lumen226 leading to the connector 132 and fluidly coupled to a pneumaticcontrol 230 (e.g., solenoids, tubing, valves, etc.) and a pump 228 forproviding the air (or other gas) which may be used for infusion into theliner 20 during a procedure. The pneumatic control 230 and/or pump 228may also be electrically coupled to the microcontroller 232 forcontrolling the operation of the pneumatic control 230. The pneumaticlumen 226 and/or pump 228 may also optionally incorporate one or moreheating elements which may be used to warm air being infused into theliner 20 in order to facilitate patient comfort and/or to facilitateremoval of the device by thawing the frozen tissue contacted by theliner.

Additionally and/or optionally, the base station 114 may also integratea temperature sensor 252 which is electrically coupled to themicrocontroller 232 and positioned within the receiving channel 222 forcontacting the reservoir 192. The temperature sensor 252 may be used tomonitor the reservoir temperature and may also be configured with one ormore heating elements which may be controlled by the microcontroller 232to regulate the temperature of the reservoir 192 in order to maintainthe system within optimal treatment parameters.

As the reservoir assembly 144 may be removable from the base station114, the reservoir assembly 144 may be secured within the receivingchannel 222 via any number of engagement mechanisms 224, e.g., threadedfeatures or other mating features which help to ensure that thereservoir is fully seated and sealed within the receiving channel 222.Because the reservoir assembly 144 may contain the power supply 190(although in other variations the power may be supplied to the basestation 114 via an external power source, e.g., wall outlet, etc.), thehousing of the assembly 144 may contain one or more electrical contacts242 which may connect with or contact complementary electrical contacts240 located on the base station 114. The electrical contacts 240 locatedon the base station 114 may be electrically coupled to the variouscomponents within the base station via a power supply connection 236 aswell as to the hand piece through connection 116 via a power supply line238. Hence, when the reservoir assembly 144 is fully seated within thebase station 114, the power supply 190 may supply the requisite to thecomponents within the base station 114 as well as the hand piece 112.

The reservoir assembly 144 is shown in the schematic view of FIG. 12removed from the base station 114. The reservoir 192, port 194,electrical contacts 242, and seal 244 are shown for clarity purposes.Because the reservoir assembly 144 may be removable from the basestation 114, the base station 114 may have the microcontroller 232programmable to detect or monitor for a mating sensor or electronics inthe assembly 144 which can be used to verify whether the reservoir 192is full or discharged, e.g., to prevent re-use of a partially emptyreservoir 192. After the end of a treatment procedure, the reservoirassembly 144 may be removed from the base station 114 to allow for theinsertion of a new reservoir assembly and the discharged reservoirassembly 144 may be either refurbished or disposed after use.

While the microcontroller 232 may be programmed to monitor the use ofthe reservoir assembly 144, the reservoir assembly 144 may also includea separate microcontroller 260 which may be electrically connected to apressure sensor 262 for monitoring a pressure level of the fluid 220within the reservoir 192 as well as being electrically connected to thepower supply 190 for determining its charge level and to the contacts242 for determining whether the power supply 190 has made sufficientcontact with the base station contacts. Aside from monitoring pressureand power levels, the base microcontroller 260 may also be programmed tomonitor various parameters of the reservoir assembly 144 such as currentor historic temperature, humidity, power levels, etc.

Additionally, the microcontroller 260 may also be programmed to lock tothe base station 114 after installation to prevent the detachment of afull or partially full reservoir assembly via optional interlocks whichmay be configured to deactivate after completion of a treatment and/orventing of the reservoir 192.

The volume of the reservoir 192 may also be varied depending on thedesired amount of fluid 220 for treatment. For instance, the reservoir192 may be configured to hold enough of the fluid 220 for a singletreatment or for multiple treatments. Alternatively, the base station114 may be integrated with a non-removable reservoir 192 so that thebase station 114 may be interfaced or connected to a large externalreservoir used to supply the fluid for treatment and/or to recharge thereservoir 192.

While illustrative examples are described above, it will be apparent toone skilled in the art that various changes and modifications may bemade therein. Moreover, various apparatus or procedures described aboveare also intended to be utilized in combination with one another, aspracticable. The appended claims are intended to cover all such changesand modifications that fall within the true spirit and scope of theinvention.

1. A treatment system, comprising: an elongate probe having a distal tipand a flexible length, at least one infusion lumen positioned through oralong the elongate probes; a liner expandably enclosing the probe suchthat a cryoablative fluid introduced through the probe is sprayed intocontact with an interior surface of the liner and coats the interiorsurface; a base having a reservoir of the cryoablative fluid; aconnection having an elongate flexible body, the connection having atleast one fluid lumen for delivery of the cryoablative fluid from thereservoir and to the at least one infusion lumen; and a controllerpositioned within the base, wherein the controller is configured tomonitor the cryoablative fluid.
 2. The system of claim 1 wherein thereservoir is removably securable within the base, the reservoir furthercomprising a power supply configured for electrical communication withthe controller when secured.
 3. The system of claim 1 wherein thereservoir further comprises electrical contacts configured toelectrically couple to the base.
 4. The system of claim 1 wherein thereservoir contains a port, the port configured to release cryoablativefluid from the reservoir.
 5. The system of claim 4 wherein the portcomprises a seal.
 6. The system of claim 5 further comprising amanifold, the manifold being configured to pierce the seal and provide apassageway for the cryoablative fluid to flow from the reservoir to theconnection.
 7. The system of claim 4 wherein the port further comprisesa valve configured to provide a passageway for the cryoablative fluid toflow from the reservoir to the connection.
 8. The system of claim 1wherein the base further comprises a pressure sensor for monitoring thepressure of the fluid in the reservoir, the controller beingelectrically connected to the pressure sensor.
 9. The system of claim 1wherein the base further comprises a pump for providing fluid into theliner, the controller being electrically connected to the pump.
 10. Thesystem of claim 1 wherein the base further comprises an exhaust pump,the controller being electrically connected to the exhaust pump.
 11. Thesystem of claim 1 wherein the base further comprises a temperaturesensor for monitoring temperature in the reservoir, the controller beingelectrically connected to the temperature sensor.
 12. The system ofclaim 1 further comprising a second microcontroller within the base. 13.The system of claim 12 wherein the second microcontroller monitorspressure levels of the reservoir and power levels of the base.
 14. Amethod of treating tissue, comprising: securing a reservoir assemblywithin a base, the reservoir assembly holding a cryoablative fluid,positioning an elongate probe having a distal tip and a flexible length,at least one infusion lumen positioned through or along the elongateprobe, expanding a liner enclosing the probe such that a cryoablativefluid introduced through the probe is sprayed into contact with aninterior surface of the liner and coats the interior surface, infusingthe cryoablative fluid from the reservoir to the at least one infusionlumen through a connection having an elongate flexible body, theconnection having at least one fluid lumen; and monitoring thecryoablative fluid with a controller positioned within the base.
 15. Themethod of claim 14 wherein monitoring the cryoablative fluid comprisesmonitoring a pressure of the cryoablative fluid using a pressure sensor.16. The method of claim 14 wherein securing a reservoir assemblycomprises detachably securing the reservoir assembly to the base. 17.The method of claim 16 further comprising electrically connecting thereservoir assembly to the base using electrical contacts.
 18. The methodof claim 14 further comprising providing a seal at a port of thereservoir.
 19. The method of claim 18 further comprising piercing theseal with a manifold, providing a passageway for the cryoablative fluidto flow from the reservoir to the connection.
 20. The method of claim 14further comprising placing a valve at a port of the reservoir, the valveconfigured to provide a passageway for the cryoablative fluid to flowfrom the reservoir to the connection.